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Completed

NCT Number: NCT04389788

Treatment of Patients With Periorbital Hyperpigmentation

Periorbital hyperpigmentation (POH) is a common condition in dermatology practice. Periorbital hyperpigmentation is defined as bilateral, round, homogeneous pigmented macules.The etiology of POH is multifactorial including genetic and enviromental factors. Many treatment options are avaiblabe with variable efficacy and safety in different patients. Therefore, the investigator's study aims to evaluate the efficacy and safety of combined microneedling with topical Glutathione versus Carboxy Therapy in treatment of patients with periorbital hyperpigmentation.

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Key information

Conditions

Periorbital Hypermelanosis

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Sohag University

Sohag, 82524, Egypt

About this study

Periorbital hyperpigmentation (POH) is a common skin condition which has a great negative effect on the patient quality of life. Many factors contribute in the pathogensis of POH which lead to developement of several treatment options with no treatment option has a great sucess in improving the POH and patient quality of life. Our current study tries to explore the efficacy and safety between 2 treatment methods in a split face study.

Microneedling is a process of making small punctres into the skin through small needles by device which is called a Dermapen. This microneedling method is beleived to be associated with improving the skin quality through increased collagen. This microneedling will be followed by topical application of glutathione which is a commong antioxidant with whitening effects.

Carboxy therapy is a new emerging treatment option in many dermatological diseases. It will be used in POH patients as it will be able to increase blood flow in periorbital area and improve the skin qulaity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Periorbital hyperpigmentation

Exclusion criteria

  • Pregnancy and lactation .
  • Allergy, hypersensitivity to the formulations to be used in the study.
  • Any other cutaneous or systemic disease.
  • Patient who had taken any other treatment (laser, dermabrasion) on the affected region performed less than 6 months prior to the beginning of the study.

Treatment and study plan

carboxy therapy

Device

6 sessions of carboxy therapy every 2 weeks

Dermapen with topical glutathione

Device

6 sessions of Dermapen microneedling with topical glutathione every 2 weeks

Primary outcomes

  1. Change of periorbital hyperpigmentation through photo evaluation

    Time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment

    High-resolution photographs of both sides of the face were taken. Using a physician visual analog scoring system, 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows 1 (worse), 2 (no change), 3 (<30%), 4 (30-60%), and 5 (>60%)

  2. Change of periorbital hyperpigmentation through dermoscopy evaluation

    Time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment

    Dermoscopic evaluation was done using dermalite connection kit for Samsung galaxy. 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows

    • Vasculature improvement (No 0, Yes 1) & percent of improvement.
    • Pigmentation improvement (No 0, Yes 1) & percent of improvement.
    • Skin improvement like atrophy and exaggerated skin markings (No 0, Yes 1) & percent of improvement.

  3. Change of the patient satisfaction evaluation: scale

    Time frame: Baseline and 1 month after end of treatment

    The patients were asked to evaluate their own level of satisfaction after they completed the study on a 1-3 scale: 1 = slightly satisfied, 2 = moderately satisfied, and 3 = well satisfied

  4. Change of periorbital hyperpigmentation into another skin problem through safety evaluation

    Time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment

    Safety evaluation to detect precentage of side effects reported either by the patient or by the physician.

Secondary outcomes

  1. The Dermatology Life Quality Index questionnaire

    Time frame: Baseline, before 3rd session, before 5th session,

    The Dermatology Life Quality Index questionnaire (DLQI) is 10 questions were asked to the patients and score is 0-3 for each question. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Efficacy and Safety of Combined Microneedling With Topical Glutathione Versus Carboxy Therapy in Treatment of Patients With Periorbital Hyperpigmentation

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.